LC Bead LUMI for Prostatic Artery Embolization: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Mean Change in IPSS Score
研究概览
简要总结
Purpose: The purpose of this pilot study is to determine preliminary estimates of the parameters related to the distribution of the study endpoints including: International Prostate Symptom Score (IPSS) and quality of life (QoL) score changes, Qmax (maximum urine flow rate) changes, post void residual volume (PVR) changes, percent prostate infarction and presence of non-target embolization.
Participants: 20 adult male subjects with benign hyperplasia will be enrolled in this study.
Procedures (methods): This will be a multisite, open label pilot study with a small population undergoing an investigational intervention (prostatic artery embolization) to determine initial safety and potential for efficacy as measured by improvement of lower urinary tract symptoms (LUTS) and decrease in prostate size.
详细描述
This will be an open label pilot study with a small population undergoing an intervention to determine initial safety and potential for efficacy as measured by improvement of LUTS and decrease in prostate size
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mean Change in IPSS Score
时间窗: Baseline and 6 months following PAE procedure
The International Prostate Symptom Score (IPSS) is an 8 item Likert questionnaire (7 symptom questions + 1 quality of life question) with scores ranging from 0 to 5, where 0 is less severe. IPSS is a written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of the symptoms of the disease benign prostatic hyperplasia (BPH). Total scores are determined to be Mild (1-7), Moderate (8-19), or Severe (20-35).
次要结局
- Mean Change in Quality of Life Scores(Baseline and 6 months following PAE procedure)
- Mean Change in Prostate Volume(Baseline and 3 months following)
- Mean Change in Urine Flow(Baseline and 6 months following PAE Procedure)
- Mean Change in IIEF Score(Baseline and 6 months following PAE procedure)
- Number of Participants That Have Minor Complications Following the Prostatic Artery Embolization (PAE) Procedure(Up to 12 months following PAE procedure)
- Percent of Prostate Infarcted(6 months following PAE procedure)
- Number of Participants That Have Non-Targeted Embolization Following the Prostatic Artery Embolization (PAE) Procedure(3 months following PAE procedure)